KEY PRODUCTS
Olpha, a JSC AB City subsidiary, is a leading Baltic firm with 50 years of experience in medicines & chemical pharmaceuticals.
01 1Olpha
01 1AMANTADINE HYDROCHLORIDE
01 1Latvia
01 1Active
01 1Complete
Olpha, a JSC AB City subsidiary, is a leading Baltic firm with 50 years of experience in medicines & chemical pharmaceuticals.
GDUFA
DMF Review : Complete
Rev. Date : 2013-11-20
Pay. Date : 2012-11-27
DMF Number : 23528
Submission : 2010-02-11
Status : Active
Type : II
20
Olpha As, based in Latvia, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
They are recognized for Olpha, a JSC AB City subsidiary, is a leading Baltic firm with 50 years of experience in medicines & chemical pharmaceuticals.
One of their notable products is AMANTADINE HYDROCHLORIDE, with a corresponding US DMF Number 23528.
Remarkably, this DMF maintains an Active status since its submission on February 11, 2010, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of November 20, 2013, and payment made on November 27, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II
